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CaRi-Heart Assessment of Risk and Evaluation of Inflammation in Coronary CT Angiography (CARE-CCTA)
Sponsor: Corazon Medical PC
Summary
This study evaluates the use of CaRi-Heart® analysis, an artificial-intelligence (AI) software tool that measures inflammation in the coronary arteries using images already captured during a standard Coronary CT Angiography (CCTA) exam. The goal is to determine whether the additional information provided by CaRi-Heart® changes clinical decision-making and helps improve early identification and management of coronary artery disease in community imaging centers. Patients who undergo CCTA as part of their regular care will be invited to have their scans analyzed using CaRi-Heart® at no extra cost, time, or radiation.
Official title: CaRi-Heart® Assessment of Risk and Evaluation of Inflammation in Coronary CT Angiography (CARE-CCTA): A Prospective U.S. Community-Based Study on the Impact of CaRi-Heart® Analysis in Patients Undergoing CCTA for Coronary Artery Disease
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
15000
Start Date
2025-12
Completion Date
2028-07
Last Updated
2025-10-23
Healthy Volunteers
No
Interventions
CaRi-Heart® Analysis
CaRi-Heart® is an artificial-intelligence-based software device that analyzes coronary CT angiography (CCTA) images to quantify coronary inflammation and generate a CaRi-Heart Risk Score. The analysis provides color-coded visualization and quantitative metrics derived from perivascular fat tissue characteristics, enabling improved assessment of coronary artery disease risk. In this study, CaRi-Heart® analysis is applied prospectively to CCTA images obtained as part of standard clinical care. The results are reviewed by the interpreting physician and recorded to determine whether the additional information affects diagnostic interpretation or management decisions. No additional imaging, radiation, or contrast exposure occurs.
Locations (18)
Corazon Imaging
Bay City, Michigan, United States
Corazon Imaging
Berkley, Michigan, United States
Corazon Imaging
Caro, Michigan, United States
Corazon Imaging
Dearborn, Michigan, United States
Corazon Imaging
Flint, Michigan, United States
Corazon Imaging
Grand Rapids, Michigan, United States
Corazon Imaging
Livonia, Michigan, United States
Corazon Imaging
Macomb, Michigan, United States
Corazon Imaging
Madison Heights, Michigan, United States
Corazon Imaging
Mount Pleasant, Michigan, United States
Corazon Imaging
Novi, Michigan, United States
Corazon Imaging
Saginaw, Michigan, United States
Corazon Imaging
Saint Clair Shores, Michigan, United States
Corazon Imaging
Sterling Heights, Michigan, United States
Corazon Imaging
Trenton, Michigan, United States
Corazon Imaging
Waterford, Michigan, United States
Corazon Imaging
Elizabethtown, Pennsylvania, United States
Corazon Imaging
Lemoyne, Pennsylvania, United States